Lurasidone HCl A Phase 3 Study of Patients With Acute Schizophrenia - Full Text View

Sponsor:	Sunovion
Information provided by (Responsible Party):	Sunovion
ClinicalTrials.gov Identifier:	NCT00615433

Purpose

Lurasidone HCl is a compound developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is more efficacious than placebo. The study will also evaluate the safety and tolerability of lurasidone as compared to placebo.

Condition	Intervention	Phase
Schizophrenia	Drug: Lurasidone Drug: Olanzapine Drug: Placebo comparator Drug: Lurasidone 40 mg tablets	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	A Phase 3 Randomized, Placebo-and Active Comparator Controlled, Clinical Trial to Study the Safety and Efficacy of Two Doses of Lurasidone HCl in Acutely Psychotic Patients With Schizophrenia.

Resource links provided by NLM:

MedlinePlus related topics: Mental Disorders Schizophrenia

Drug Information available for: Olanzapine Lurasidone Lurasidone hydrochloride

U.S. FDA Resources

Further study details as provided by Sunovion:

Primary Outcome Measures:

Change in Total PANSS (Positive and Negative Syndrome Scale)Score From Baseline to the End of the Double Blind Treatment Period. [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
The PANSS is a 30-item rating instrument evaluating the presence/absence and severity of positive, negative and general psychopathology of schizophrenia. The scale was developed from the BPRS and the Psychopathology Rating Scale. All 30 items are rated on a 7-point scale (1=absent; 7=extreme). The total score can range from 30 to 210. Lower scores represent less severity of illness.

Secondary Outcome Measures:

CGI-S (Clinical Global Impression - Severity) Change From Baseline to the End of the Double-blind Treatment. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
The CGI-S is a clinician-rated assessment of the subject's current illness state on a 7-point scale, where a higher score is associated with greater illness severity.

Enrollment:	478
Study Start Date:	January 2008
Study Completion Date:	January 2010
Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Lurasdione 40mg tablets	Drug: Lurasidone 40 mg tablets Lurasidone 40 mg tablets
Experimental: 120mg	Drug: Lurasidone 120mg/day
Active Comparator: 15mg Olz	Drug: Olanzapine 15mg/day
Placebo Comparator: Sugar pill	Drug: Placebo comparator Placebor Comparator

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Provide written informed consent and aged between 18 and 75 years of age.
Meets DSM-IV criteria for a primary diagnosis of schizophrenia.
Not pregnant, if of reproductive potential agrees to remain abstinent or use adequate and reliable contraception for duration of study.
Able and agrees to remain off prior antipsychotic medication for the duration of study.
Good physical health on the basis of medical history, physical examination, and laboratory screening.
Willing and able to comply with the protocol, including the inpatient requirements and outpatient visits.

Exclusion Criteria:

Considered by the investigator to be at imminent risk of suicide or injury to self, others or property.
Any chronic organic disease of the CNS (other than schizophrenia).
Used investigational compound within 30 days.
Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00615433

Show 52 Study Locations

Sponsors and Collaborators

Sunovion

Investigators

Study Director:

Medical Director, MD

Sunovion

More Information

No publications provided

Responsible Party:	Sunovion
ClinicalTrials.gov Identifier:	NCT00615433 History of Changes
Other Study ID Numbers:	D1050231
Study First Received:	February 1, 2008
Results First Received:	November 8, 2010
Last Updated:	September 6, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sunovion:

Schizophrenia
Latuda
Lurasidone

Additional relevant MeSH terms:

Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Olanzapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 24, 2012